Senior Manager, Clinical Trial Management – FSP

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Lead cross-functional trial teams and execute end-to-end clinical trial delivery • Build and deliver trial operational plans • Oversee trial delivery, budgets, timelines, quality, milestones, and protocol deviation resolution pathways • Identify, set up, and oversee CROs/vendors, statements of work, budgets, KPIs, and performance • Ensure trial deliverables and milestones meet corporate and study-level goals • Identify risks and implement mitigations and contingencies • Ensure compliance with global health authority regulations, guidelines, and internal procedures • Participate in Health Authority Inspections and internal QA audits • Maintain inspection readiness and collaborate with R&D Quality on quality oversight • Participate in trial- and department-level process improvement activities • Mentor and support onboarding of new team members, particularly in Study Management • Liaise with Finance, Program Management, Vendor Management, Safety, Accounting, Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, and Medical Affairs • Analyze budget variance and notify Finance of projected cost over/under expenditure • Support and provide input into internal governance presentations and updates

🎯 Requirements

• BS/BA degree is required • Minimum 7+ years of clinical research experience gained directly with a CRO, Biotech or Pharmaceutical Company leading Phase 1–4 global clinical trials end to end • 3–5 years of direct experience leading end-to-end global clinical trials • Experience overseeing/leading global trials outsourced to a CRO vendor and managing all aspects of clinical trial execution • Excellent decision-making, analytical, and financial management skills • Excellent leadership skills and ability to foster team productivity and cohesiveness • Ability to operate and execute with limited supervision • Experience leading without authority in multifunctional, matrixed, and global environments • Experience mentoring/coaching others • Exceptional organizational skills and ability to manage competing priorities • Strong reasoning and problem-solving ability • Strong project planning/management, written and verbal communication, and presentation skills • Proficiency with MS Office Suite (Excel, Word, PowerPoint) and MS Project

🏖️ Benefits

• Equal opportunity employer • Ability to travel approximately 10% with flexibility according to business need